RECRUITING

Organization-level Youth Engagement Approach for Substance Misuse Prevention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase 1 will consist of a small pilot Open Trial (OT). The objective of Phase 1 is to develop an organization-level Youth Engagement (YE) prevention strategy and implement it in a community-based organization to test feasibility and acceptability in an open trial with one organization. This will include developing a manual for systematically incorporating YE into prevention efforts in community settings. Phase 2 will consist of a small pilot Randomized Controlled Trial (RCT). Four prevention organizations will be randomized either to include Youth Engagement in prevention efforts (treatment) or not (control). The study team will attempt to match the treatment and control groups on relevant characteristics such as geographic location (e.g., urban, rural), population served (e.g., church-based, school-based), and/or prior Youth Engagement involvement. The objective of the second phase of this study is to evaluate the preliminary effectiveness of YE as a prevention strategy for opioid misuse in a small pilot randomized control trial (RCT). This pilot study will examine the effects of the YE prevention strategy on (a) organization-level outcomes, such as perceived value added to prevention programming and (b) individual-level outcomes such as personal skills and attitudes as well as knowledge and attitudes about substances including opioids. Up to 15 leaders/staff and 45 youth/young adults (60 people overall) will be recruited for the study.

Official Title

Organization-level Youth Engagement Approach for Substance Misuse Prevention

Quick Facts

Study Start:2024-03-14
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Leaders or staff of community-based prevention organizations based in North Carolina
  2. * Organizations are youth/young adult-serving and focused on opioid misuse prevention
  3. * Organizations demonstrate readiness, interest, need, and resources to invest in Youth Engagement as part of prevention
  4. * Leaders or staff are or would be involved in implementing Youth Engagement strategy at the organization
  5. * Leaders or staff are able to speak and read English fluently
  6. * Adolescents and young adults age 11 - 29
  7. * Interested in participating in YE with the community organization
  8. * Able to speak and read English fluently
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Parissa J Ballard, PhD
CONTACT
336-716-0793
pballard@wakehealth.edu
Taylor Arnold
CONTACT
336-713-5019
tjarnold@wakehealth.edu

Principal Investigator

Parissa J Ballard, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Parissa J Ballard, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-14
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2024-03-14
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Adolescents
  • Young adults
  • Prevention
  • Youth Engagement
  • Randomized control trial

Additional Relevant MeSH Terms

  • Drug Use
  • Substance Use
  • Opioid Use
  • Substance Misuse